{"adverse_reactions":["ADVERSE REACTIONS Post-marketing Experience No adverse events have been reported with a causal relationship to Spascupreel® injection solution. To report SUSPECTED ADVERSE REACTIONS, contact MediNatura. at 1.844.633.4628 or info@medinatura.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch ."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Mechanism of Action The exact mechanism of Spascupreel® Injection Solution is not fully understood. Pharmacodynamics Not applicable for homeopathic medicinal products."],"contraindications":["CONTRAINDICATIONS Spascupreel ® Injection Solution is contraindicated in patients with known hypersensitivity to Spascupreel ® or any of its ingredients."],"description":["DESCRIPTION Each 1.1 ml solution for injection ampule contains: Active Ingredients: Ingredient name Potency Quantity Final dilution Aconitum napellus 6X 2.20 µl 8.69X Agaricus muscarius 4X 0.55 µl 7.30X Ammonium bromatum 4X 1.10 µl 7.00X Atropinum sulphuricum 6X 1.10 µl 8.99X Chamomilla 3X 0.55 µl 6.30X Colocynthis 4X 1.10 µl 7.00X Cuprum sulphuricum 6X 0.55 µl 9.30X Gelsemium sempervirens 6x 1.10 µl 8.99X Magnesia phosphorica 6X 1.10 µl 8.99X Passiflora incarnata 2X 0.55 µl 5.30X Veratrum album 6X 1.10 µl 8.99X Inactive Ingredients: Water for injection 1,089.0 μl Sodium Chloride 10.4 μl"],"description_table":["
Each 1.1 ml solution for injection ampule contains:
Active Ingredients:
Ingredient name Potency Quantity Final dilution
Aconitum napellus 6X 2.20 µl 8.69X
Agaricus muscarius 4X 0.55 µl 7.30X
Ammonium bromatum 4X 1.10 µl 7.00X
Atropinum sulphuricum 6X 1.10 µl 8.99X
Chamomilla 3X 0.55 µl 6.30X
Colocynthis 4X 1.10 µl 7.00X
Cuprum sulphuricum 6X 0.55 µl 9.30X
Gelsemium sempervirens 6x 1.10 µl 8.99X
Magnesia phosphorica 6X 1.10 µl 8.99X
Passiflora incarnata 2X 0.55 µl 5.30X
Veratrum album 6X 1.10 µl 8.99X
"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION General Considerations The dosage schedules listed below can be used as a general guide for the administration of Spascupreel® Injection Solution. Spascupreel® Injection Solution may be administered s.c., i.d., i.m., or i.v. If co-administration with a local anesthetic is desired, Spascupreel ® Injection Solution may be mixed with lidocaine or similar agents at the discretion of the physician. The interval between injections is left to the discretion of the HCP, but should not exceed 1 ampule in 24 hours. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard any unused ampule contents. Draw up required dose into syringe. Discard any unused ampule contents. Do not reuse ampule. Only licensed practitioners with sufficient expertise in injecting drugs, including the respective route of administration, should administer the product. Standard Dosage: Adults and children 12 years and older: 1 ml 1 to 3 times per 7 days. Children 6 to 11 years: 0.7 ml 1 to 3 times per 7 days. Children 2 to 5 years: 0.5 ml 1 to 3 times per 7 days. Acute Dosage: Adults and children 12 years and older: 1 ml daily, and then continue with standard dosage. Children 6 to 11 years: 0.7 ml daily, and then continue with standard dosage. Children 2 to 5 years: 0.5 ml daily, and then continue with standard dosage."],"dosage_forms_and_strengths":["DOSAGE 1 ampule containing 1.1 ml solution for injection."],"effective_time":"20211014","id":"72a712a7-7d1f-436c-8f18-ddbc97047ce4","indications_and_usage":["INDICATION AND USAGE Spascupreel® Injection Solution is a homeopathic drug product indicated for the relief of spasms of the smooth musculature of the gastrointestinal and the urogenital tract as well as general muscle spasms."],"openfda":{},"package_label_principal_display_panel":["Spascupreel 1.1ml Injection.jpg"],"set_id":"eb57106f-320a-4abc-bffc-987dfb87909b","spl_product_data_elements":["Spascupreel ACONITUM NAPELLUS, AMMONIUM BROMIDE, CITRULLUS COLOCYNTHIS FRUIT PULP, ATROPINE SULFATE, GELSEMIUM SEMPERVIRENS ROOT, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, VERATRUM ALBUM ROOT, PASSIFLORA INCARNATA FLOWERING TOP, MATRICARIA RECUTITA, AMANITA MUSCARIA FRUITING BODY and CUPRIC SULFATE ACONITUM NAPELLUS ACONITUM NAPELLUS AMMONIUM BROMIDE BROMIDE ION CITRULLUS COLOCYNTHIS FRUIT PULP CITRULLUS COLOCYNTHIS FRUIT PULP ATROPINE SULFATE ATROPINE GELSEMIUM SEMPERVIRENS ROOT GELSEMIUM SEMPERVIRENS ROOT MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE MAGNESIUM CATION VERATRUM ALBUM ROOT VERATRUM ALBUM ROOT PASSIFLORA INCARNATA FLOWERING TOP PASSIFLORA INCARNATA FLOWERING TOP MATRICARIA RECUTITA MATRICARIA RECUTITA AMANITA MUSCARIA FRUITING BODY AMANITA MUSCARIA FRUITING BODY CUPRIC SULFATE CUPRIC CATION SODIUM CHLORIDE WATER"],"version":"15","warnings_and_cautions":["WARNINGS AND PRECAUTIONS Keep out of reach of children."]}